Kornimate/medical-research-clean huggingface dataset:
continued access protocol for the evaluation of the optimizer smart system

Conditions: Heart Failure; Congestive Heart Failure; Chronic Heart Disease; CHF

Summary: this is a multicenter, prospective, single-arm continued access study of the optimizer smart system with ccm therapy.

the continued access study is a prospective, non-randomized, multi-center study designed to allow controlled access to the optimizer smart system until the pma order has been issued by the fda.

Eligibility criteria:
inclusion criteria: 1. subjects who are 18 years of age or older 2. subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography. 3. subjects who, in the opinion of the investigator (based on the current guidelines for clinical practice), have been treated for heart failure for at least 90 days and are currently receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure. 4. subjects who are in new york heart association functional class iii and iv at the time of enrollment. 5. subjects who are willing and able to return for all follow-up visits. exclusion criteria: 1. subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease. 2. subjects receiving any form of inotropic support within 30 days before enrollment, including subjects on continuous iv inotrope therapy. 3. subjects hospitalized for decompensated heart failure requiring acute treatment with intravenous loop diuretics, iv inotropes or hemofiltration within 30 days before enrollment and baseline testing. 4. subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 pvcs per 24 hours on baseline holter monitoring. 5. subjects having a pr interval greater than 375ms. 6. subjects who are scheduled for a cabg or a ptca procedure, or who have undergone a cabg procedure within 90 days or a ptca procedure within 30 days of enrollment. 7. subjects who have a biventricular pacing system, an accepted indication for such a device, or a qrs width of 130ms or greater. 8. subjects who have had a myocardial infarction within 90 days of enrollment. 9. subjects who have mechanical tricuspid valve. 10. subjects who have a left ventricular assist device or prior heart transplant. 11. subjects on dialysis. 12. subjects who are participating in another experimental protocol. 13. subjects who are unable to provide informed consent.

Keywords: cardiac contractility modulation ccm fix-hf-5ca continued access
integrated psychological program for management of postnatal depression and persistent postpartum pain after childbirth

Conditions: Depression, Postpartum

Summary: the integrated psychological program (ipp) is based on evidence from the local population showing that the interventional components (mindfulness training, music listening, video counselling) are amenable to implementation in the outpatient care setting. incorporating innovative digital mobile and electronic applications in the care of an increasingly technology-savvy population will be strategic. the proposal will transform the healthcare model for treating postnatal depression (pnd) and persistent postpartum pain (ppp).

the childbirth process is associated with the risk of developing postnatal depression (pnd) and persistent postpartum pain (ppp), which could contribute to maternal morbidity. there is a lack of routine structured and effective programs in current practice to monitor and effectively manage pnd and ppp. pilot study found specific pain and psychological vulnerability factors associated with increased risk of pnd after childbirth. the investigators propose an integrated psychological program (ipp) consisting of mindfulness mobile application, music listening, digital health video counselling and mobile electronic survey to effectively prevent, detect, monitor, and treat pnd and ppp. the primary aim is to determine whether the use of the ipp will result in lower incidence of pnd after childbirth. the study will also determine whether the use of the ipp will result in lower postnatal edinburgh postnatal depression scale (epds) scores in a subgroup of laboring women (with outcomes of vaginal or emergency cesarean delivery) that may have increased risk factors for pnd. the interplay of psychological and pain factors during the use of the ipp will also be determined using patient centric outcomes (mother-child bonding, breastfeeding self-efficacy, quality of life). a total of 1480 women undergoing childbirth will be recruited in this randomized controlled trial. this proposal has the potential to recommend guidelines in community care and to incorporate digital health in management of pnd and ppp. the ipp will also provide patient-centered care tailored to the individual's needs and will have an immediate potential to improve transition of hospital to community care in postnatal women health.

Eligibility criteria:
inclusion criteria: * healthy (american society of anesthesiologists physical status 2) * parturient women at term (36 weeks' gestation or more, nulliparous and multiparous); * with a singleton fetus; * to have delivery in this institution. exclusion criteria: * current active psychiatric care; * history of intravenous drug or opioid abuse; * previous history of chronic pain syndrome.
motor adaptation to split-belt treadmill in parkinson's disease

Conditions: Parkinson Disease; Freezing of Gait

Summary: freezing of gait (fog) is a disabling symptom common in advanced parkinson's disease. fog is an independent contributor to fall risk and is only partially relieved by medication. parkinson's patients with fog are known to have more difficulty with gait adaptation in their day to day environment. further, asymmetry of gait has been implicated in fog as these episodes are often elicited during asymmetric tasks such as turning. this study will examine the effect of a single session of split-belt treadmill walking on gait adaptation, gait symmetry and fog as well as 24 hour retention of these effects.

in this proposal, the investigators will investigate whether adapting gait to modulations imposed by a split-belt treadmill, improves walking ability and reduces fog. the investigators will test the hypothesis that motor adaptation deficits underlie fog and that these problems are modifiable with training. to address these suppositions, the investigators propose a multi-centric study conducted in two research labs with expertise in split-belt gait analysis and fog: university of leuven (kul) and christian-albrechts-university kiel (cauk). as freezers have been shown to have more difficulty with consolidation of motor learning, the investigators aim in study i (pilot phase) to first understand which split-belt parameters are optimal for training gait flexibility and lead to consolidated gains in daily walking. for this study, the investigators will recruit 60 freezers and 60 healthy controls, pooled across centers, and manipulate different split-belt conditions in one learning and retention session.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease as per the uk parkinson's disease society brain bank criteria * classification as a freezer with the new freezing of gait questionnaire (score \> 0) * ability to walk at least 5 min. without any aid * stable anti-parkinsonian medication at least 1 month prior to participation exclusion criteria: * neurologic diseases other than pd * orthopedic injuries that could influence gait and balance * participation in treadmill training more than once a week * cognitive impairment (mmse\<24) or inability to follow test instructions * self-reported dbs-related postural or gait disturbances * cardiovascular risk factors * peripheral neuropathy

Keywords: split-belt treadmill training
transplantation of bone marrow mesenchymal stem cell in crohn's disease

Conditions: Crohn's Disease

Summary: this study is a prospective, randomized, parallel, phase 1 trial to assess the safety and feasibility of the transplantation of bone marrow derived mesenchymal stem cells (mscs) in fistulizing crohn's disease.

in this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group a receives only autologous mscs suspended in fibrin glue, group b receives autologous mscs+ fibroblasts. both groups receive 4 injections inside the wall and lumen of the fistula. injections will be repeated every month.

Eligibility criteria:
inclusion criteria: * 1- poor response to routine treatments in refractory crohn's disease with fistula. 2- cdai\>220 3- age 18 to 60 years 4- gfr\>30, cr\<2 5- the presence of perinea fistula. exclusion criteria: * pregnancy

Keywords: crohn's disease mesenchymal stem cell fistula
ketamine versus midazolam for prehospital agitation

Conditions: Agitation

Summary: this research study is being done to figure out the best approach to treatment of pre-hospital agitation. it will compare two tiered dosing treatment protocols, one ketamine-based and one midazolam-based. agitation is a state of extreme emotional disturbance where patients can become physically aggressive or violent, endangering themselves and those who are caring for them. often chemical substances or severe mental illness are involved in this level of agitation. specifically, the investigators are interested in studying agitation that is treated in the prehospital setting by paramedics. this study's hypothesis is a ketamine-based protocol will achieve a faster time to adequate sedation than a midazolam-based protocol for treatment of agitation in the prehospital environment. this study will observe the natural history of an emergency medical services standard operating procedure change from a ketamine-based protocol to a midazolam-based protocol.


Eligibility criteria:
inclusion criteria: * age 18 or older * severe agitation (amss +2 or +3) or profound agitation (amss +4) requiring chemical sedation * transport to hennepin county medical center exclusion criteria: * obviously gravid women * patients known or suspected to be less than 18 years of age * patients in which stopwatch activation, for safety reasons, is unable to occur

Keywords: agitation, ketamine, midazolam, emergency medical services
pluto: pediatric lipid-reduction trial of rosuvastatin

Conditions: Familial Hypercholesterolemia

Summary: the primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing ldl-c in children and adolescents aged 10-17 years with hefh from baseline (day 0) to the end of the 12-week double-blind treatment period.


Eligibility criteria:
inclusion criteria: * male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (hefh) exclusion criteria: * certain medical conditions and lab test results * history of a reaction to rosuvastatin or other statin drugs * use of specified disallowed medications

Keywords: heterozygous familial hypercholesterolemia
effect of preoperative anxiety on postoperative delirium in elderly patients undergoing orthopaedic surgery.

Conditions: Delirium; Anxiety

Summary: postoperative delirium is a common and important complication in patients. the aim of this study was to investigate whether preoperative anxiety predicted onset of postoperative delirium in elderly patients undergoing orthopaedic surgery, so as to help develop preventive approaches.


Eligibility criteria:
inclusion criteria: * aged 65 or older * patients undergoing elective orthopaedic surgery * asa i-iii exclusion criteria: * history of craniocerebral trauma surgery or severe central nervous system disease * inability to read or understand the informed consent documents * too physically or psychologically ill
advent post approval study

Conditions: Paroxysmal Atrial Fibrillation

Summary: the advent post approval study (pas) is a prospective, global, multicenter, observational study.

the objective of advent pas is to evaluate the long-term safety and effectiveness profile of the farapulse pulsed field ablation system when used to perform pulmonary vein isolation (pvi) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (paf).

Eligibility criteria:
inclusion criteria: * subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (paf) who are indicated for a treatment with the farapulse pulsed field ablation (pfa) system\*; (subjects refractory, or intolerant or contraindicated to at least one class i or iii antiarrhythmic medication or contraindicated to any class i or iii medications.) * subjects who are willing and capable of providing informed consent; * subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site; * subjects who are of legal age to give informed consent specific to the national law. * for the lux-dx sub-study: subjects with an existing lux-dx insertable cardiac monitor (icm), inserted ≥ 180 days prior to enrollment, or having a lux-dx icm inserted per the investigator's standard of care, up to 7 days after the ablation procedure. subjects with or having a lux-dx icm inserted per standard of care, up to 7 days after the ablation procedure. exclusion criteria: * subjects with any known contraindication to an af ablation or anticoagulation, including those listed in the instructions for use (ifu); * subjects with any prior left atrium (la) ablation; * subjects who may need an ablation in the left atrium besides pvi, such as for left-sided atrioventricular reentrant tachycardia (avrt), left-sided atrial tachycardia (at) or atypical left-sided atrial flutter (afl); * women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion); * life expectancy of \< 1 year, per investigator's medical judgement.

Keywords: pulsed field ablation pfa pulmonary vein isolation pvi ablation atrial fibrillation af
role and mechanisms of obesity surgery

Conditions: Obesity; Bariatric Surgery; Physical Activity; Post-operative Complications; Quality of Life

Summary: the purpose of this study is to examine how physical activity and lifestyle factors influence postoperative recovery and postoperative complications after bariatric surgery. the hypothesis is that physically active people, with a healthy alcohol consumption and non smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations and fewer re-operations, fewer complications as well as a faster recovery after a surgical procedure. the investigators also hypothesize that possible risk factors for non-surgical postoperative complications e g abdominal discomfort are also life-style related factors such as smoking, high alcohol consumption, low level of physical activity, as well as other risk factors such as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of anxiety and/or depression, difficulties with coping with the changed food intake regimen after obesity surgery, and generally high sensitivity for painful-sensations and nausea. first aim of this study is to investigate how life style factors prior to obesity surgery are related to hospital stay, sick-leave, immediate postoperative complication rates and the rate of resumption of qol and normal physical function. the second aim of the study is to identify risk factors for the development of chronic abdominal discomfort and dumping symptoms after obesity surgery.


Eligibility criteria:
inclusion criteria: * \>18 y of age * bmi \>35 exclusion criteria: * non-knowledgeable in swedish language
evaluation of a digital childhood obesity treatment

Conditions: Childhood Obesity; Treatment Adherence

Summary: this study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. the hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in bmi sds) and reduce the number of missed visits.

childhood obesity treatment is time consuming for both the health care system, and for the involved families. there is an association between the intensity and the outcome of treatment. in this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. the digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of bmi standard deviation score (sds). the app also provides an individual target curve visualizing the expected weight journey. weight in growing children is complex to interpret why bmi sds is used. objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app. the evaluation will be carried out when approximately 120 children have had the opportunity to be treated with the support system for one year. the results will be compared with a matched control group from the boris childhood obesity treatment register.

Eligibility criteria:
inclusion criteria: * obesity according to international obesity task force (iotf) exclusion criteria: * no

Keywords: mobile health support system behavioral treatment self-monitoring
perioperative vitamin c to reduce persistent pain after total knee arthroplasty

Conditions: Chronic Pain; Knee Pain Chronic; Post Operative Pain

Summary: phase ii multicentre, pilot, parallel-group, blinded, 1:1 randomized controlled trial to determine the feasibility of conducting a larger definitive trail of using vitamin c to reduce persistent pain in patients undergoing total knee arthroplasty surgery.

provision is a multicentre, pilot, parallel-group, blinded, randomized controlled trial of 300 patients undergoing total knee arthroplasty surgery. consented eligible patients will be randomized to receive vitamin c: 2000 mg taken orally within 4 hours of the start of surgery, followed by 500 mg of vitamin c taken twice daily from post-operative day 1 to day 56 (8 weeks). patient in the control group will receive placebo lactose monohydrate capsules. study medications will be prepared to look similar and labelled as per regulatory requirements. patients will follow up on post-operative days 1-3, weeks 2,4,6, and 8 post-operatively, and at 3- and 12-months post-operatively to report on pain, opioid and analgesic consumption, medication adherence, adverse events, functional, mood, and quality of life outcomes.

Eligibility criteria:
inclusion criteria: * patients \>18 years old * undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee exclusion criteria: * tka for infection (septic joint), fracture, ankylosing spondylitis, lupus, or psoriatic arthritis * history of kidney stones, acute or chronic renal failure, hemochromatosis, or glucose-6-phosphate deficiency * unlikely to comply with follow-up (e.g., no fixed address, plans to move out of town) * language difficulties that would impede valid completion of questionnaires * planned staged bilateral tka * treating surgeon deems patient inappropriate for inclusion in trial * any allergy or sensitivity to milk * pregnant or planning to become pregnant during the study
molecular profiling project

Conditions: Lung Cancer; Non-Small Cell Lung Cancer

Summary: in this study, the investigators plan to undertake comprehensive molecular profiling of "actionable" alterations in lung cancer specimens in order to determine the prevalence of each genetic subtype in the local population.

atorg is undertaking a comprehensive molecular profiling of "actionable" alterations in lung cancer specimens in order to determine the prevalence of each genetic subtype. these mutations are screened using the oncomine focus assay, where 52 genetic alterations - including hotspots, single nucleotide variants, indels, cnvs, and gene fusions - may be detected in a single workflow. oncomine™ comprehensive assay v3, an ngs assay which tests for 161 unique genes (appendix iv), will be used in a later stage of the study, allowing for broader coverage of potentially targetable alterations. both assays have a rapid turnaround time and addresses one of the main challenges of solid tumor testing - the scarcity of tissue material - requiring minimal sample input and thus enabling the use of a wider range of sample quality and types, including small biopsies and fine needle aspirates. however, as the list of therapeutically relevant biomarkers continues to expand over time, broader ngs panels will be used subsequently to incorporate emerging alterations. in addition, relevant baseline clinical characteristics are collated e.g. patient demographics, smoking history, number of lines of therapy, as well as outcomes including access to targeted therapies, immune checkpoint inhibitors and overall survival. through comprehensive annotation of clinical-pathological-molecular characteristics, this study will provide a means to rationalize the application of diagnostic tests, as well as identify prognostic and predictive factors in the treatment of asian lung cancers.

Eligibility criteria:
inclusion criteria: * the availability of sufficient archival tumor tissue specimen (15 slides of 4 microns per section) * age ≥ 21 years * who performance status ≤ 2 * life expectancy of ≥ 12 weeks * patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment): * adequate bone marrow function as shown by: anc ≥ 1.0 x 10\^9/l, platelets ≥ 75 x 10\^9/l, hb ≥ 7.5 g/dl * alanine aminotransferase (alt) and aspirate aminotransferase (ast) normal range (or ≤3.0 x uln if liver metastases are present) * willing to provide signed informed consent * patients whom do not fulfill the above criteria may be discussed on a case-by-case basis with the study team, for potential enrolment exclusion criteria: - no more than 3 lines of cytotoxic chemotherapy at the time of enrolment

Keywords: oncomine focus panel assay molecular profiling targeted therapies driver oncogene next-generation sequencing (ngs) pd-l1 immunohistochemistry (ihc, dako 22c3) hotspots single nucleotide variants (snvs) insertions/ deletions (indels) copy number variation (cnvs), gene fusions formalin-fixed paraffin embedded (ffpe) extracted dna and rna ion pgm™ system oncomine™ comprehensive assay v3